AAR: ‘conditional yes’ deals will speed innovation uptake

The strategic review looking at how to create a pathway for innovations of value to England’s NHS has produced its interim report.

The Accelerated Access Review (AAR) was kick-started by George Freeman, the government minister for Life Sciences and, as such, aims to help the pharmaceutical, biotech, medtech and digital health sectors gain greater uptake in the NHS.

The review has been chaired by Sir Hugh Taylor, who knows only too well the challenges facing the NHS currently, as he is chair of Guys and St Thomas’ NHS Trust in London, one of the country’s leading hospitals.

As the interim report acknowledges, the review comes as the NHS faces a huge financial crisis, so it recommends ways in which innovation adoption can be aligned with efficiency drives and efforts to improve patient outcomes.

Its five key propositions are:

Putting the patient centre stage: Patients should be given a stronger voice at every stage of the innovation pathway.

Getting ahead of the curve: A radically new approach is required to accelerate and manage entry into the health system for the emerging products that promise the most significant, potentially transformative, impact in terms of patient benefit and overall value.

Supporting all innovators: In addition to accelerating access to a select number of the most promising new products, the end-to-end innovation pathway can, and should, also be more responsive to the wider, irrepressible surge of innovation presented at all levels of the system, particularly where its introduction will contribute to better outcomes for patients and more productive and efficient ways of delivering care.

Galvanising the NHS: The NHS must be an active partner in promoting innovation, and must be incentivised to adopt new products and systems quickly and effectively.

Delivering change: Building on existing health system structures, a new system architecture is required at local and national level to accelerate access to the best new products and related models of care on a sustainable basis, within a framework of collective agreement to ambitions and goals.

Managed access

The report says England’s NHS and life sciences environment must undergo a fundamental shift towards a more proactive approach to build on many exciting, forward-thinking developments, such as the 100,000 Genomes Project and the Catapult network of innovation incubators.

The report notes: “We are simultaneously in the most exciting era in recent times for health innovation, and in a time when all international health economies, including ours, are facing unprecedented cost pressures and constraints. This is a challenge our health system cannot ignore.”

As expected, the AAR says this can be addressed by a more co-ordinated approach to innovation adoption, through a managed access system.

It says this can be best described as a ‘conditional yes’ decision, leading to agreements between companies and the health system that both specify requirements for access, and control financial risk.

It says this would involve ‘some form of conditionality – financially or performance-based, or a combination of the two’ and it would be supported by new, more flexible approaches to reimbursement over the period of the managed access agreement.

This is very much in line with what other leading organisations have called for – just last week the ABPI’s Paul Catchpole and the Cancer Drugs Fund chair Professor Peter Clark voiced similar views.

However, as always, the devil is in the detail, and the AAR has deliberately not put forward a detailed plan of how this system should work.

The AAR states that a new, flexible system could include simple discounts, but also more complex schemes such as price-volume agreements, multi-year agreements conditional on the achievement of certain outcomes, patient cost caps or free/discounted treatment initiation.

The report says any new initiatives in England and the UK should be combined with a ‘continued drive’ to accelerate pathways at a European level and to plan for the effects of European Union regulatory changes.

Changes for NICE and AHSNs

The report said it was also considering how NICE could develop a ‘stronger’, more ‘flexible’ and ‘streamlined’ system for evaluating pharmaceuticals and medtech products – combined with a more streamlined process for evaluating ‘non-NICE’ products at regional level in the NHS.

It also proposes strengthening England’s existing regional Academic Health Science Networks (AHSN), giving them more power to bridge the gap between commercial innovators and the NHS.

Delivery

The report makes it clear that co-ordination at a national level, and uptake at a local level, are major barriers.

To address the former, it suggests the creation of a national Innovation Partnership to manage the innovation pathway ‘seamlessly at national level, supporting the rapid and sustainable introduction of innovative products’.

The organisations involved would include the NIHR, MHRA, NICE, NHS England and NHS Improvement.

Can the current pricing deal deliver this?

Commenting on the interim report, Alison Clough, acting chief executive of the Association of the British Pharmaceutical Industry (ABPI), said: “We know that the UK lags behind many countries in providing our patients with access to new medicines and we are pleased that this interim report takes on board a number of ABPI recommendations to address this.”

She added that the report’s recognition of the need to ‘invest to save’ was a significant step forward.

However the report’s recommendations for a new, multi-faceted approach to market access raises the question of whether this could be achieved within the current Pharmaceutical Price Regulation Scheme (PPRS).

The PPRS deal, which runs until the end of 2018, provides a cap on NHS medicines budgets via rebates from the industry once spending exceeds certain limits.

Clough stated that the five-year scheme “provides a unique opportunity to ensure that this report is turned into operational reality for the benefit of patients, the NHS and the UK as a whole.”

This position suggests the ABPI will not want to abandon the stability of the current PPRS, particularly as the alternative would bring a great deal of uncertainty and renegotiation.

The ABPI said it looks forward to working with the review team, NHS and other stakeholders, to “consider how they can practically deliver these exciting proposals and make the changes required.”

The AAR team welcomes further feedback on its propositions and provisional

conclusions, and will set out its final recommendations in Spring 2016.